========================================
SAFE HEART WOMEN STUDY - PHASE 1 DATA
========================================

DATASET INFORMATION
-------------------
Dataset Title: SAFE HEART Phase 1 Data
Full Study Name: Social Determinants of the Risk of
                 Hypertension in Women of Reproductive Age
                 (SAFE HEART) Study
Principal Investigator: Dr. Yvonne Commodore-Mensah
Institution: Johns Hopkins University
Grant Number: 979462
IRB Protocol: IRB00337704
Data Collection Period: July 2022 - July 2024
Dataset Created: November 2025
Deposit Date: November 2025

IMPORTANT NOTE:
This data deposit includes PHASE 1 DATA ONLY.
Phase 2 data collection is ongoing (grant period extends
through summer 2026) and will be deposited upon completion
in accordance with AHA Open Science Policy timelines.

Total Observations:
  - Phase 1 Baseline: 573 participants
    * Registry-enrolled participants
    * Community-enrolled participants
  - Phase 1 Follow-up (Intervention cohort): 140 participants
    * Community-enrolled intervention participants only

STUDY DESCRIPTION
-----------------
BACKGROUND:
The SAFE HEART study is part of the American Heart Association
Research Goes Red Initiative. It examines the association between
cardiovascular health literacy (CVHL), social determinants of
health (SDoH), and cardiovascular health (CVH) among women of
reproductive age at increased risk of developing hypertension.

PRIMARY OBJECTIVE:
To evaluate the cross-sectional association of CVHL, SDoH using
a polysocial score, and CVH in women of reproductive age at
increased risk of developing hypertension.

SECONDARY OBJECTIVE:
To assess whether a 4-month active health education intervention
results in a change in CVHL among community-enrolled women.

STUDY DESIGN:
Cross-sectional study with two enrollment groups:
1. Registry-enrolled: Women from the Research Goes Red (RGR)
   registry
2. Community-enrolled: Women recruited from Baltimore and
   Washington D.C. communities to enhance racial, ethnic, and
   socioeconomic diversity

INTERVENTION (Phase 1 Community-Enrolled Participants):
A subset of Phase 1 community-enrolled participants received a
4-month active health education intervention focused on
cardiovascular health literacy. Follow-up assessments were
conducted post-intervention.

DATA COLLECTED:
- Baseline social phenotyping
- Detailed social determinants of health questionnaire
- Cardiovascular health (CVH) metrics assessment
- Cardiovascular health literacy (CVHL) assessment
- Physical measurements (blood pressure, BMI, body composition)
- Biochemical measurements (glucose, lipid panel)
- 4-month health education intervention (community-enrolled subset)
- Post-intervention follow-up assessments (intervention cohort)

POPULATION FOCUS:
The study focuses on racial and ethnic minority groups and
socioeconomically disadvantaged women of reproductive age.
These findings inform future development of community-engaged
strategies that address CVHL and SDoH among women of
reproductive age.

For complete study design and rationale, see:
Metlock, F. E., Kwapong, Y. A., Evans, C., Ouyang, P.,
Vaidya, D., Aryee, E. K., Nasir, K., Mehta, L. S.,
Blumenthal, R. S., Douglas, P. S., Hall, J.,
Commodore-Mensah, Y., & Sharma, G. (2024).
Design and rationale of the social determinants of the
risk of hypertension in women of reproductive age
(SAFE HEART) study: An American Heart Association
research goes red initiative. American Heart Journal,
275, 151-162. https://doi.org/10.1016/j.ahj.2024.05.016

FILES IN THIS REPOSITORY
------------------------
1. SAFE_HEART_Phase1_Data.xlsx
   - Sheet 1: Phase1_Baseline (573 participants)
   - Sheet 2: Phase1_Followup_Intervention (140 participants)
2. Data_Dictionary.xlsx - Variable definitions for both datasets
3. README.txt - This file

EXCEL FILE STRUCTURE
--------------------
The data file contains TWO sheets:

SHEET 1: Phase1_Baseline (n=573)
  - Baseline data for all Phase 1 participants
  - Registry-enrolled participants
  - Community-enrolled participants (includes intervention cohort)
  - Cross-sectional baseline assessments
  - All participants have phase=0

SHEET 2: Phase1_Followup_Intervention (n=140)
  - Follow-up data for Phase 1 intervention cohort ONLY
  - Community-enrolled participants who completed 4-month
    health education intervention
  - Post-intervention assessments
  - Can be linked to baseline data via studyid_phase1

PARTICIPANT IDENTIFIERS
-----------------------
PRIMARY IDENTIFIER (both sheets):
  studyid_phase1
    - Sequential identifier: 1 to 573
    - Complete: 0 missing values
    - Use to link baseline and follow-up data
    - De-identified
    - USE THIS ID for all analyses

ORIGINAL IDENTIFIERS (retained for transparency):
  study_id - Original study ID
  subjid - Original subject ID
  participant_id_csp - Original CSP participant ID
  NOTE: These may have missing values and should not be
  used as primary identifiers

DATA STRUCTURE
--------------
- Format: Microsoft Excel (.xlsx) with 2 sheets
- First row: Variable names
- Phase 1 Baseline: Rows 2-574 (n=573)
- Phase 1 Follow-up: Rows 2-141 (n=140)
- Missing data: Blank/empty cells

VARIABLE INFORMATION
--------------------
See Data_Dictionary.xlsx for complete variable documentation.
The dictionary includes a 'dataset' column indicating which
sheet each variable belongs to.

Key Variable Categories:
  - Participant identifiers (studyid_phase1, phase)
  - Demographics (age, race/ethnicity, education, employment)
  - Socioeconomic status (income, housing, insurance)
  - Social determinants of health (housing, food security,
    transportation, safety, social isolation)
  - Mental health (depression, anxiety, stress, chronic stressors)
  - Health history (chronic conditions, pregnancy history)
  - Health behaviors (smoking, physical activity, diet, sleep)
  - Cardiovascular health literacy (heart disease knowledge)
  - Physical measurements (BP, height, weight, BMI, body composition)
  - Biochemical measurements (glucose, HbA1c, lipid panel)
  - Healthcare access and quality

MISSING DATA
------------
Missing data shown as blank cells in Excel.
Reasons may include:
  - Participant non-response
  - Items not applicable to specific participants
  - Variables collected only at baseline or follow-up
  - Registry-enrolled vs. community-enrolled differences
  - Lost to follow-up (intervention cohort)
  - Skip patterns in questionnaire

NOTE: Not all Phase 1 baseline participants have follow-up data.
Follow-up data is only available for the community-enrolled
intervention cohort. Check Data_Dictionary.xlsx for patterns
in missing data.

DATA DE-IDENTIFICATION
----------------------
De-identified per HIPAA Safe Harbor guidelines:
  - Direct identifiers removed (names, addresses, full dates,
    phone numbers, email addresses)
  - Dates generalized or converted to relative time periods
  - Geographic data limited to ZIP code level
  - Ages >89 top-coded to 90
  - Original numeric IDs retained but cannot be linked to
    individual participants
  - New sequential identifier (studyid_phase1) created

DATA ANALYSIS GUIDANCE
----------------------
CROSS-SECTIONAL ANALYSES:
  - Use Sheet 1 (Phase1_Baseline)
  - N=573 participants
  - All participants have baseline measurements

INTERVENTION EFFECT ANALYSES:
  - Link Sheet 1 (baseline) to Sheet 2 (follow-up)
  - Match by studyid_phase1
  - Only intervention cohort has follow-up data (n=140)
  - Consider using paired analysis methods

REGISTRY VS. COMMUNITY-ENROLLED:
  - Variable to distinguish groups may be available in dataset
  - Check Data_Dictionary.xlsx for enrollment type variable

DATA USE AND CITATION
---------------------
These data are made freely available for research and
educational purposes in accordance with the American Heart
Association Open Science Policy.

REQUIRED CITATION:
When using these data, please cite:
Commodore-Mensah, Y., Metlock, F. E., Kwapong, Y. A.,
Evans, C., Ouyang, P., Vaidya, D., Aryee, E. K., Nasir, K.,
Mehta, L. S., Blumenthal, R. S., Douglas, P. S., Hall, J.,
& Sharma, G. (2025). SAFE HEART Phase 1 Data:
Social Determinants of the Risk of Hypertension in Women
of Reproductive Age [Data set]. American Heart Association.
[https://doi.org/XXXXX - to be assigned]

ADDITIONAL CITATION REQUIREMENTS:
  - Acknowledge the American Heart Association funding
    (Grant #979462)
  - Reference the study design paper (see Related Publications)
  - If analyzing baseline and follow-up separately, indicate
    this clearly in methods
  - If analyzing registry-enrolled vs. community-enrolled
    separately, indicate this clearly in methods

CONTACT INFORMATION
-------------------
For questions about this dataset, please contact:
Principal Investigator: Dr. Yvonne Commodore-Mensah
Email: ycommod1@jh.edu
Institution: Johns Hopkins University School of Nursing

INSTITUTIONAL REVIEW BOARD
--------------------------
IRB Institution: Johns Hopkins Medicine
Protocol Number: IRB00337704
Study Status: Active (Phase 2 data collection ongoing)

FUNDING
-------
This study is supported by:
  American Heart Association
  Grant Number: 979462
  Program: Research Goes Red Initiative

TERMS OF USE
------------
By using this dataset, you agree to:
  - Cite the dataset appropriately in all publications and
    presentations
  - Not attempt to identify individual participants
  - Use data for research and educational purposes only
  - Comply with all applicable laws and regulations
  - Acknowledge the American Heart Association funding in all
    outputs
  - Not redistribute the data without permission
  - Report any suspected data quality issues to the PI

RELATED PUBLICATIONS
--------------------
Study Design and Methods:
Metlock, F. E., Kwapong, Y. A., Evans, C., Ouyang, P.,
Vaidya, D., Aryee, E. K., Nasir, K., Mehta, L. S.,
Blumenthal, R. S., Douglas, P. S., Hall, J.,
Commodore-Mensah, Y., & Sharma, G. (2024).
Design and rationale of the social determinants of the
risk of hypertension in women of reproductive age
(SAFE HEART) study: An American Heart Association
research goes red initiative. American Heart Journal,
275, 151-162. https://doi.org/10.1016/j.ahj.2024.05.016

Cardiovascular Health Literacy:
Metlock, F. E., Rayani, A., Stanislas, K. A., Vaidya, D.,
Kwapong, Y. A., Hladek, M. D., Ouyang, P., Hall, J. L.,
Sharma, G., & Commodore-Mensah, Y. (2025).
Cardiovascular health literacy among women of reproductive
age in the SAFE HEART Study: An American Heart Association
Research Goes Red Initiative. Health Literacy Research
and Practice. [DOI to be added when available]

FUTURE DATA RELEASES
--------------------
Phase 2 data will be deposited upon completion of data
collection and analysis (expected summer 2026 or within
12 months of final publication, in accordance with AHA
Open Science Policy).

Users of Phase 1 data may wish to check for Phase 2 data
availability for complete study findings.

VERSION HISTORY
---------------
Version 1.0 - November 2025
  - Initial Phase 1 data deposit
  - Phase 1 baseline data (n=573)
  - Phase 1 follow-up intervention cohort (n=140)
  - Data collection: July 2022 - July 2024 (Phase 1 only)
  - Phase 2 data excluded (grant period extends to summer 2026)
  - Created studyid_phase1 identifier

========================================
END OF README
Last Updated: November 2025
========================================
